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TARGET BP I Clinical Trial (TARGET BP I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02910414
Recruitment Status : Recruiting
First Posted : September 22, 2016
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Ablative Solutions, Inc.

Brief Summary:
The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group (without renal denervation - no alcohol infusion). Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central randomization.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Dehydrated alcohol Device: Peregrine System Kit (Sham Procedure) Phase 3

Detailed Description:

The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group (without renal denervation - no alcohol infusion). Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central randomization.

The TARGET BP I clinical trial uses a percutaneous catheter to deliver very small amounts of alcohol (neurolytic agent). The patient population for this trial is comparable to those used in other renal denervation studies, but also incorporates lessons learned from recent trials of renal denervation. This is to enable the study of an optimized patient population who stands to benefit from the intervention, in a manner that reduces possible study bias.

This trial is intended to evaluate the safety and efficacy of the Peregrine Catheter when used to deliver a 0.6 mL volume of alcohol to the perivascular area of the respective renal arteries while patients are adequately managed with oral antihypertensive medications.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects With Hypertension
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treated with Peregrine System Kit
The experimental group will receive an infusion of Dehydrated Alcohol Injection, USP into the perivascular space of the renal arteries with the Peregrine Catheter. A total of 0.6mL of the alcohol will be delivered to the perivascular space of each renal artery. The drug will only be delivered once to each renal artery during the treatment procedure.
Drug: Dehydrated alcohol
Dehydrated Alcohol Injection, USP is used in the study.
Other Name: Ethanol

Sham Comparator: Peregrine System Kit (Sham Procedure)
The sham control group will have a percutaneous procedure in which the Peregrine Catheter is delivered to the renal artery, but the needles will not be deployed and no alcohol will be delivered to the perivascular space of the renal arteries.
Device: Peregrine System Kit (Sham Procedure)
The Peregrine Catheter is delivered to the renal arteries, but the needles are not deployed and no alcohol is delivered to the perivascular space.




Primary Outcome Measures :
  1. Change in mean systolic ABPM [ Time Frame: 3 months ]
    The change in mean 24-hour ambulatory SBP from baseline to 3 months post-procedure


Secondary Outcome Measures :
  1. Proportion of subjects with major adverse events [ Time Frame: 30 days ]
    Major Adverse Events as defined in the clinical protocol

  2. Major Adverse Events [ Time Frame: 3, 6, and 12 months and 2 and 3 years ]
    Major Adverse Events as defined in the clinical protocol

  3. Decrease in eGFR > 25% [ Time Frame: 3 and 6 months ]
    Decrease in eGFR > 25% at 3 and 6 months

  4. Changes in eGFR [ Time Frame: 3 and 6 months ]
    Changes in eGFR at 3 and 6 months

  5. Adverse event rate [ Time Frame: Procedure date, discharge date (an average of 1 day), 5-day, 4 weeks, 8 weeks, 3 months, 4 months, 5 months, 6 months, 1 year, 2 years and 3 years ]
    Adverse event rate at procedure, discharge, and at all follow-up visits

  6. Device success [ Time Frame: Procedure date (day 0) ]
    Device success, defined as successful introduction of the catheter, navigation to the treatment site, deployment of the needles, and infusion of the alcohol to the intended area via the Peregrine Catheter as intended for use

  7. Procedure success [ Time Frame: Hospital discharge date (an average of 1 day) ]
    Procedure success defined as device success and freedom from serious adverse events related to the product or the procedure, during the procedure and prior to hospital discharge from the index procedure.

  8. Change of office systolic blood pressure [ Time Frame: 8 weeks ]
    Change of office systolic blood pressure from baseline to 8 weeks

  9. Change of diastolic office blood pressure [ Time Frame: 3 and 6 months ]
    Change of diastolic office blood pressure from baseline to 3 and 6 months

  10. Change of 24-hour mean diastolic ABPM [ Time Frame: 3 and 6 months ]
    Change of 24-hour mean diastolic ABPM from baseline to 3 and 6 months

  11. Change of 24-hour mean systolic ABPM [ Time Frame: 6 months ]
    Change of 24-hour mean systolic ABPM from baseline to 6 months

  12. Changes in antihypertensive regimen [ Time Frame: 3 months ]
    Changes in antihypertensive regimen from procedure to 3 months post-procedure

  13. ABPM responders (5 mmHg) [ Time Frame: 3 months ]
    ABPM Responders, defined as the proportion of subjects with a drop of ≥5 mmHg in 24-hour ambulatory SBP at 3 months compared with baseline.

  14. Office BP responders (10 mmHg) [ Time Frame: 3 months ]
    Office BP Responders, defined as the proportion of subjects with a drop of ≥10 mmHg in office SBP at 3 months compared with baseline.

  15. Change in mean office SBP [ Time Frame: 6 months ]
    Change in mean office SBP from baseline to 6 months post-procedure

  16. Change in mean daytime ambulatory SBP [ Time Frame: 3 months ]
    Change in mean daytime ambulatory SBP from baseline to 3 months post procedure.

  17. Change in mean daytime ambulatory SBP [ Time Frame: 6 months ]
    Change in mean daytime ambulatory SBP from baseline to 6 months post procedure.

  18. Change in mean daytime ambulatory DBP [ Time Frame: 3 and 6 months ]
    Change in mean daytime ambulatory DBP from baseline to 3 months and then 6 months post procedure.

  19. Changes (decreases or increases) in antihypertensive medication regimen from 3 months to 6 months post-procedure [ Time Frame: 3 and 6 months ]
    Changes (decreases or increases) in antihypertensive medication regimen from 3 months to 6 months post-procedure (titrated according to standardized formula to maintain a target office SBP of < 140 mmHg and ≥ 90 mmHg).

  20. Changes (decreases or increases) in antihypertensive medication regimen from procedure to 6 months post-procedure [ Time Frame: 6 months ]
    Changes (decreases or increases) in antihypertensive medication regimen from procedure to 6 months post-procedure (titrated according to standardized formula to maintain a target office SBP of <140 mmHg and ≥90 mmHg)

  21. Change in mean nighttime ambulatory SBP [ Time Frame: 3 and 6 months ]
    Change in mean nighttime ambulatory SBP from baseline to 3 months and then 6 months post procedure.

  22. Change in mean nighttime ambulatory DBP [ Time Frame: 3 and 6 months ]
    Change in mean nighttime ambulatory DBP from baseline to 3 months and then 6 months post procedure.

  23. Reduction of office SBP and DBP to normal [ Time Frame: 3, 6, and 12 months ]
    Reduction of office SBP and DBP to normal (<140/90 mmHg) at 3, 6 and 12 months as compared to baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has 3 office blood pressure measurements with a mean office systolic blood pressure (SBP) of ≥150 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of ≥90 mmHg when receiving 2 to 5 antihypertensive medications.
  2. Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings

Exclusion Criteria:

  1. Subject has renal artery anatomy abnormalities.
  2. Subject has an estimated glomerular filtration rate (eGFR) of ≤45 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; or is on chronic renal replacement therapy.
  3. Subject has documented sleep apnea.
  4. Subject has any of the following conditions: severe cardiac valve stenosis, heart failure (New York Heart Association [NYHA] Class III or IV), chronic atrial fibrillation, and known primary pulmonary hypertension (>60 mmHg pulmonary artery or right ventricular systolic pressure).
  5. Subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only).
  6. Subject is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive medications, or immunosuppressive doses of steroids. Aspirin therapy and nasal pulmonary inhalants are allowed.
  7. Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910414


Contacts
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Contact: Deborah Schmalz +1 (650) 688-9743 dschmalz@ablativesolutions.com
Contact: Debbie Reynolds, PhD +1 (650) 688-9743 dreynolds@ablativesolutions.com

Locations
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United States, Alabama
Cardiology PC Recruiting
Birmingham, Alabama, United States, 35211
Contact: Farrell Mendelsohn, MD         
United States, Georgia
Piedmont Heart Institute Recruiting
Atlanta, Georgia, United States, 30309
Contact: David Kandzari, MD         
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Tayo Addo, MD         
Sponsors and Collaborators
Ablative Solutions, Inc.
Investigators
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Principal Investigator: David Kandzari, MD Piedmont Heart Institute
Principal Investigator: Michael Weber, MD SUNY Downstate Medical
Principal Investigator: Atul Pathak, MD Clinique Pasteur
Principal Investigator: Felix Mahfoud, MD Klinik fur Innere Medizin III
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Responsible Party: Ablative Solutions, Inc.
ClinicalTrials.gov Identifier: NCT02910414    
Other Study ID Numbers: CR0002
First Posted: September 22, 2016    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Ablative Solutions, Inc.:
Renal Denervation
Alcohol
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs